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RECRUITING
NCT06003283
PHASE4

Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis. The main questions it aims to answer are: * What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact? * What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy? Participants will be randomized to one of two study arms: * Tapering based on disease-activity guided dose reduction (experimental arm) * Tapering based on interval prolongation (active comparator arm)

Official title: Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2024-01-09

Completion Date

2027-12

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

DRUG

Rituximab

IV rituximab

Locations (7)

ZNA Jan Palfijn

Merksem, Antwerpen, Belgium

Cliniques Universitaires Saint-Luc Bruxelles

Brussels, Brussels Capital, Belgium

Reumacentrum Genk

Genk, Limburg, Belgium

ReumaClinic Genk

Genk, Limburg, Belgium

OLV Aalst

Aalst, Oost-Vlaanderen, Belgium

RZ Heilig Hart

Leuven, Vlaams-Brabant, Belgium

University Hospitals Leuven (UZ Leuven)

Leuven, Vlaams-Brabant, Belgium